Quality Audit Management

Offering efficient management of audit records data, meeting audits scheduling and planning requirements, addressing all quality audit management challenges, such as audit planning and conflict resolution, participant confirmation, audit preparation, audit conducting,observations and CAPAs remediation, auditor’s skills management, resources management etc. Generica QMS offline tool for auditors ensures comprehensive tracking of audit processes by enabling easy management of all actionable information and critical processes.

Generica QMS is used for managing Quality Audit processes, including Internal sites and External supplier Audits, Auditors Management, Suppliers Management and Pharmacovigilance Audit. The Quality Audit Management module can be implemented as an independent solution or as an integrated module among a comprehensive Quality Management platform provided by Generica QMS.


Thanks to Generica's smooth integration with tools such as Word, Excel, and PDF, users may remain in their familiar work environment, whereas all actionable information and critical processes can seamlessly become "Smart Objects" within Generica straight from their original document. Alongside significantly improving users productivity, Generica Quality Audit enhances monitoring and control, and ensures comprehensive tracking.


To achieve full coverage of Quality Audit Management the following functionality is available, supporting all types of Quality Audit processes, as mentioned above:


  • Yearly/Quarterly audit planning

  • Plan conflicts resolving and participants confirmation

  • Audit preparation based on past audits and inspections

  • Audit conducting with FDA and EMA Checklists assistance

  • Site responses collection, responsibility acceptance, and CAPAs

  • Generate and sign reports (Electronic signature 21 CFR part 11)

  • Observations and CAPAs management


  • Inspections and Inspection observations management

  • New inspection observations rollout and sharing

  • Review, check, fix and confirm capabilities

  • Inspectors management

  • Audit preparation based on past inspections


  • Suppliers and manufacturing management

  • External suppliers management

  • External suppliers qualification

  • External supplier information sharing


  • Auditors qualifications management based on auditors’ skill set

  • Resources management


  • Full search, statistic and trends

  • Management dashboards & graphs (management, auditors, site QA head)

  • Periodic reports

  • Powerful and flexible permissions for users and groups

  • Related Risk Assessment